Using 18F-florbetaben PET-CT to Diagnose Cardiac AL Amyloidosis

A Multi-center Phase 3 Study of 18F-florbetaben Positron Emission Tomography/Computed Tomography (PET-CT) to Non-invasively Diagnose Cardiac AL Amyloidosis

This study is testing if a special type of imaging called 18F-florbetaben PET-CT can help doctors diagnose heart problems caused by AL amyloidosis in patients who show symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 95 Years
• Sex: All
• Sponsor: Fondazione Toscana Gabriele Monasterio (Academic / other)
• Locations: 1 site (Pisa)
• Trial ID: NCT06048601 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of 18F-florbetaben PET-CT imaging in non-invasively diagnosing cardiac amyloidosis, specifically focusing on amyloid light-chain (AL) amyloidosis. The study will involve patients who exhibit symptoms indicative of cardiac involvement due to amyloidosis, utilizing advanced nuclear medicine techniques to identify amyloid deposits in the heart. By improving diagnostic accuracy, the trial seeks to facilitate timely treatment interventions for affected patients.

Who should consider this trial

Good fit: Ideal candidates for this study are men and women over 18 years old who show clinical signs compatible with cardiac amyloidosis and have specific NT-proBNP or echocardiogram results.

Not a fit: Patients with severe chronic kidney disease, those who cannot undergo PET/CT imaging, or those in advanced heart failure (NYHA class IV) may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier and more accurate diagnoses of cardiac AL amyloidosis, improving patient outcomes.

How similar studies have performed: While the use of nuclear medicine techniques for diagnosing cardiac amyloidosis is emerging, this specific approach with 18F-florbetaben PET-CT is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Men and women aged \>18 years;
* Ability to understand, sign and date the informed consent;
* NT-proBNP values\> 332 ng/L in the absence of renal in-sufficiency or atrial fibrillation or mean left ventricular wall thickness \>12 mm on echocardiogram and / or a pat-tern of circumferential or diffuse late gadolinium en-hancement and/or BNP \>81 ng/L, in a clinical setting seemed compatible with CA by experienced doctors.

Exclusion Criteria:

* Hypersensitivity to the active principle or any excipient listed in the paragraph 6.1 of the Summary of Product Characteristics (RCP) of Neuraceq®;
* Severe chronic kidney disease (estimated glomerular filtra-tion rate \<30 mL/min/1.73 m2);
* Performing a PET/CT or scintigraphic exam within 24 hours;
* Impossibility to lay flat for about 60 minutes;
* New York Heart Association (NYHA) class IV;
* Pregnancy or breastfeeding, women with childbearing po-tential and sexually active not employing highly effective contraceptive methods with a low dependency on the user (from the screening to the end of visit 1), which include: i. abstinence, ii. sexual intercourse only with same-sex part-ners, iii. monogamous relationship with a partner with pri-or vasectomy, iv. intrauterine device, v. combined hormo-nal contraception including estrogens and progesteron-like hormones plus the inhibition of ovulation (oral, intravagi-nal or transdermal), vi. hormonal contraception based on progesterone-like compounds plus the inhibition of ovula-tion (oral, injectable, implantable), viii. intrauterine device with hormone release. The highly effective contraceptive measures above are not required for women made sterile by surgical means (for example through tube ligation, hys-terectomy, bilateral salpingectomy, bilateral ovariectomy) or after the menopause, defined as 12 months of spontane-ous amenorrhea without another clinical cause and with el-evated FSH levels in agreement with the expected values for the menopause. For patients with true abstinence or with just same-sex partners, contraception is not required, as far as this is in line with their preferred and habitual lifestyle. Periodical abstinence (for example, estimate of the timing of ovulation or assessment of body temperature) and coitus interruptus are not acceptable contraceptive methods. If a patient stops to be abstinent, she must use the highly effective contraceptive methods above.

The pregnancy status in women potentially fertile will be checked through the measurement of beta human gonado-tropin on the serum and repeated at the end of the study;

* Participation to a study involving the administration of an experimental drug within 30 days from the screening or 5 half-lives of the study drug, whichever the longest;
* Lack of informed consent or impossibility to complete study procedures.

Where this trial is running

Pisa

• Fondazione Toscana Gabriele Monasterio — Pisa, Italy (Recruiting)

Conditions Amyloid; Amyloid Cardiomyopathy